Pharmacokinetic Properties of Lorcaserin in Obese or Overweight Elderly Subjects

This study has been completed.
Sponsor:
Information provided by:
Arena Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00828581
First received: January 22, 2009
Last updated: January 23, 2009
Last verified: January 2009
  Purpose

The purpose of this study is to evaluate the PK properties of lorcaserin in obese or overweight elderly subjects.


Condition Intervention Phase
Obesity
Drug: lorcaserin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: An Open-Label, Single-Dose Study of the Pharmacokinetic Properties of Lorcaserin in Obese or Overweight Elderly Subjects

Resource links provided by NLM:


Further study details as provided by Arena Pharmaceuticals:

Primary Outcome Measures:
  • To compare the single-dose pharmacokinetic (PK) parameters of lorcaserin in the obese or overweight Elderly (> 65) to those obtained from the obese or overweight Adult (18-65) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety and tolerability of a single oral dose of lorcaserin in obese or overweight Elderly (> 65) subjects and obese or overweight Adult (18-65) subjects. [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: October 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lorcaserin Drug: lorcaserin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females
  2. Control (Adult) group: aged between 18 and 65 years (inclusive)
  3. Elderly group: aged > 65 years (includes subjects 1 day or more beyond the 65th birthday)
  4. Able to give signed informed consent
  5. BMI 27-45 kg/m2, inclusive 6. Eligible male and female subjects must agree not to participate in a conception process (i.e. active attempt to become pregnant or to impregnate, egg or sperm donation, in vitro fertilization).
  6. Considered to be in stable health in the opinion of the Investigator

Exclusion Criteria:

  1. Prior participation in any study of lorcaserin.
  2. Clinically significant new illness in the 1 month before screening
  3. Not suitable to participate in the study in the opinion of the Investigator including an existing physical or mental condition that prevents compliance with the protocol
  4. History of any of the following cardiovascular conditions:

    • Myocardial infarction (diagnosed by cardiac enzyme[s] and/or diagnostic ECG), cerebral vascular accident (CVA), transient ischemic attack (TIA) or reversible ischemic neurologic deficit (RIND) within 6 months of screening
    • Cardiac arrhythmia requiring initiation of new medical or surgical treatment within 6 months of screening (stable medical therapy for > 6 months, pacemakers and/or defibrillators implanted > 6 months prior to screening are acceptable)
    • Unstable angina
    • History of pulmonary artery hypertension
  5. Positive result of HIV, hepatitis B or hepatitis C screens
  6. Initiation of a new prescription medication within 1 month prior to screening with the following exceptions:
  7. Use of SSRIs, SNRIs, and other medications must meet washout period.
  8. Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to screening
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00828581

Locations
United States, New Jersey
CRI Worldwide - Lourdes Hospital
Willingboro, New Jersey, United States, 08046
Sponsors and Collaborators
Arena Pharmaceuticals
Investigators
Investigator: Christen Anderson, MD, PhD Arena Pharmaceuticals
  More Information

No publications provided

Responsible Party: Christen Anderson, MD, PhD, Arena Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00828581     History of Changes
Other Study ID Numbers: APD356-018
Study First Received: January 22, 2009
Last Updated: January 23, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014